Percutaneous heart pump transitionable between separated and operational configurations

ABSTRACT

Disclosed herein is a catheter pump that includes an expandable cannula and an impeller system. The expandable cannula defines a blood flow channel and includes an impeller blade zone, an inlet zone, and an outlet zone. The catheter pump further includes an impeller system including an impeller body, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump. The catheter pump is selectively transitionable between a separated configuration in which the impeller body is axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to provisional application Ser. No.62/661,717, filed Apr. 24, 2018, which is incorporated herein in itsentirety.

BACKGROUND OF THE DISCLOSURE a. Field of the Disclosure

The present disclosure relates generally to percutaneous heart pumpsincluding an expandable cannula and an impeller body movable withrespect to the expandable cannula along a longitudinal axis. Morespecifically, the present disclosure relates to a percutaneous heartpump, or a catheter pump, that has a separated configuration, whereinthe impeller body and the expandable cannula are axially spaced from oneanother along a longitudinal axis of the catheter pump, and anoperational configuration, wherein the impeller body is positioned atthe same axial position as the expandable cannula.

b. Background

Heart disease is a major health problem that claims many lives per year.After a heart attack or other major cardiac event, only a small numberof patients can be treated with medicines or other non-invasivetreatment. A significant number of patients, however, can recover from aheart attack or other cardiac event if provided with mechanicalcirculatory support in timely manner.

In one conventional approach for treating patients, a blood pump havinga fixed cross-section is surgically inserted a heart chamber, such asinto the left ventricle of the heart and the aortic arch, to assist thepumping function of the heart. Other known conventional applicationsinvolve providing for pumping venous blood from the right ventricle tothe pulmonary artery for support of the right side of the heart. Theobject of the surgically inserted pump is to reduce the load on theheart muscle for a period of time, which may be as long as a week,allowing the affected heart muscle to recover and heal. In some cases,surgical insertion may potentially cause additional stresses in heartfailure patients.

In many cases, insertion of a left ventricular assist device (LVAD), aright ventricular assist device (RVAD), or in some cases a system forboth sides of the heart (sometimes called biVAD) is a desirablealternative. The pump component of the device includes an impellerencased in a housing or expandable cannula, while blood, driven by theimpeller, traverses the interior or lumen of the housing. Devices suchas these, referred to as percutaneous heart pumps (PHPs), are oftensheathed in a delivery device prior to being inserted percutaneouslyinto the patient. The housing or expandable cannula is collapsible, orcompressible, under a certain amount of force applied by the sheath. Theforce required to compress and sheath the housing or expandable cannulais increased when the impeller is located within the housing orexpandable cannula, due to the size of the impeller.

It is desirable to reduce the sheathing force of PHPs to reduce the riskof damaging the housing or expandable cannula and the impeller. It isfurther recognized that the smaller the delivery profile of the sheathedcatheter, the more readily it may be introduced into the patient'svasculature. However, it is also recognized that a larger operationalprofile enables increased blood flow at a lower impeller rotationalvelocity. Accordingly, a PHP maintaining a sufficiently small deliveryprofile and a sufficiently large operational profile, while reducing thenecessary sheathing force is desired.

SUMMARY OF THE DISCLOSURE

The present disclosure is directed to a catheter pump including anexpandable cannula defining a blood flow channel and including animpeller blade zone, an inlet zone, and an outlet zone. The catheterpump further includes an impeller system including an impeller body, theimpeller system movable relative to the expandable cannula along alongitudinal axis of the catheter pump. The catheter pump is selectivelytransitionable between a separated configuration in which the impellerbody is axially spaced from the expandable cannula along thelongitudinal axis, and an operational configuration in which theimpeller body is positioned within the impeller blade zone of theexpandable cannula.

The present disclosure is further directed to a method of delivering acatheter pump having an expandable cannula and an impeller system to atarget site. The method includes placing the catheter pump in aseparated configuration, in which an impeller body of the impellersystem is axially spaced from the expandable cannula along alongitudinal axis of the catheter pump, maneuvering the expandablecannula and impeller system to the target site while the catheter pumpis in the separated configuration, and transitioning the catheter pumpfrom the separated configuration to an operational configuration at thetarget site, wherein, in the operational configuration, the impellerbody is located at the same axial position as the expandable cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a heart pump system configured forpercutaneous application and operation.

FIG. 2 illustrates one embodiment of a catheter assembly adapted to beused with the heart pump assembly of FIG. 1.

FIG. 3 illustrates a schematic view of the catheter assembly shown inFIG. 2.

FIG. 4A illustrates one embodiment of a catheter assembly in a separatedconfiguration.

FIG. 4B illustrates the catheter assembly of FIG. 4A in an operationalconfiguration.

FIG. 5A illustrates another embodiment of a catheter assembly in aseparated configuration.

FIG. 5B illustrates the catheter assembly of FIG. 5A in an operationalconfiguration.

FIG. 6A illustrates an actuator for use with the catheter assemblies ofFIGS. 3A, 3B, 4A, and 4B in a separated configuration.

FIG. 6B illustrates the actuator of FIG. 6A in an operationalconfiguration.

FIG. 7A illustrates another embodiment of an actuator for use with thecatheter assemblies of FIGS. 3A, 3B, 4A, and 4B in a separatedconfiguration.

FIG. 7B illustrates the actuator of FIG. 7A in an operationalconfiguration.

FIG. 8 is a flow diagram illustrating one embodiment of a method fordelivering a catheter assembly to a target site.

DETAILED DESCRIPTION OF THE DISCLOSURE

Percutaneous heart pumps (PHP), also referred to as catheter pumps, andcomponents of the present disclosure can be used to treat individualsexperiencing cardiac stress, including acute heart failure. Inparticular, the catheter pumps of the present disclosure are configuredsuch that the expandable housing, or expandable cannula, of the catheterpump and the impeller body are axially movable relative to one anotheralong a longitudinal axis. Consequently, i.e., the expandable cannulaand impeller body can be axially separated from one another in aseparated configuration during delivery and/or removal, significantlyreducing the force required to collapse components of the catheter pump.

Separating the impeller body and the expandable cannula reduces thecross-sectional delivery profile of the PHP as compared to a moreconventional configuration where the impeller body is located within theexpandable cannula during delivery. In embodiments of the PHP describedherein, the impeller body moves longitudinally relative to theexpandable cannula to enable each component to be collapsed, orcompressed, individually (e.g., using a sheath or other deliverydevice), thereby achieving a reduced delivery profile while in theseparated configuration. The reduced delivery profile eases percutaneousinsertion of the PHP into the patient, and further enables the PHP toutilize a larger profile when the expandable cannula and impeller bodyexpand to assume their operational shape and size. The impeller body isthen moved longitudinally, and relative to the expandable cannula, inthe proximal direction into an impeller blade zone of the expandablecannula. This defines the operational configuration.

An actuating mechanism for switching between the separated andoperational configurations is located in the handle of the catheter. Theimpeller body moves longitudinally and proximally until a mechanicalstop, e.g., a proximal bearing, positions it correctly in the impellerblade zone of the expandable cannula. In some embodiments, a followermagnet is included in the actuator mechanism. The follower magnetcouples a motor to the impeller body only when the impeller system isproperly positioned within the expandable cannula. This safety featuredecreases opportunity for error and misuse of the PHP.

Additionally, axial separation of the impeller body and the expandablecannula renders a full-length hypotube unnecessary. Such a hypotube, orguidewire guide, enables tracking of a guidewire during insertion of thePHP through the patient's circuitous vasculature. However, with suchPHPs, the guidewire and guidewire guide are removed after insertion ofthe PHP and, notably, the guidewire cannot be reinserted into thepatient and the PHP cannot be repositioned without complete removal ofthe PHP from the patient. If the PHP is reusable, which is typically notthe case, then the guidewire is reinserted into the catheter assemblyand the PHP may be reinserted into the patient. More likely, the PHP isnot reusable and must be discarded. Consequently, a new PHP andguidewire are needed. In either case, repeated introductions of the PHPmay increase the duration of the procedure. In embodiments of thestaggered PHP described herein, the guidewire may be reinserted withoutremoving the PHP from the patient, which enables repositioning the PHPif necessary without the drawbacks associated with reintroducing thesame or a new PHP and guidewire.

a. Catheter Pump System Overview

Referring now to the Figures, and specifically to FIG. 1 and FIG. 2,there is illustrated one embodiment of a heart pump 10 (note that heartpump and catheter pump are used interchangeably herein) that includes acatheter assembly 100 having a proximal end 104 adapted to connect to amotor 14 and a distal end 108 (shown in FIG. 2) adapted to be insertedpercutaneously into a patient (not shown). Motor 14 is connected by asignal line 18 to a control module 22 that provides power and/or controlsignals to motor 14. Heart pump 10 may have an infusion system 26 and apatient monitoring system 30.

Infusion system 26 can provide a number of benefits to heart pump 10. Inone embodiment, infusion system 26 includes an infusant source 34, afluid conduit 38 extending from infusant source 34 to proximal end 104of catheter assembly 100, and a fluid conduit 42 extending from proximalend 104 of catheter assembly 100 to a waste container 46. The flow of aninfusant to and from catheter assembly 100 can be by any means,including a gravity system or one or more pumps. In FIG. 1, infusantsource 34 includes an elevated container 50, which may contain saline oranother infusant as necessary based on patient requirements. Flow fromelevated container 50 can be regulated by a pressure cuff 54 (e.g., toelevate the pressure of the fluid in container 50 to increase flow), bya pinch valve 58, and/or by other suitable means.

With further reference to FIG. 1, patient monitoring system 30 enablesmonitoring the operation of the patient and/or pump 10. For example,patient monitoring system 30 can include a user interface 60 coupledwith data source 64. Data source 64 can include one or more patientcondition sensors, such as pressure sensors 68 that are in pressurecommunication with the patient and/or operating components within thepatient. In one embodiment, pressure sensors 68 fluidly communicate by aconduit 72 that extends between the sensors and a proximal portion ofcatheter assembly 100. Conduit 72 can include a plurality of separablesegments and can include a valve 76 to enable or disable the pressurecommunication to sensors 68.

Heart pump 10 is adapted to provide an acute or other short-termtreatment. A short-term treatment can be for less than a day or up toseveral days or weeks in some cases. With certain configurations pump 10can be used for a month or more.

FIG. 2 illustrates one embodiment of catheter assembly 100 that may beused with heart pump 10 (shown in FIG. 1). An impeller system 180(described in detail herein) disposed at distal end 108 is configured topump blood proximally or distally through or along a portion of heartpump 10 to convey blood from one body cavity to another. Impeller system180 includes an impeller body 308. Impeller system 180 can be arrangedto pump blood distally, such as in a right heart assist mode to moveblood from the right ventricle to the pulmonary artery. On contrast,proximal flow is optimal for left heart support to move blood from theleft ventricle to the aorta. Heart pump 10 can be used to treat patientswith acute heart failure, ST elevation myocardial infarction (STEMI),cardiac arrest, cardiac arrhythmia or other heart conditions as notedabove. Heart pump 10 also can be used in connection with a surgicaltreatment to support the patient without providing full cardiovascularbypass. A patient could be supported on the device for longer term withproper controls and design.

One feature that facilitates percutaneous insertion is configuringcatheter assembly 100 to have a relatively low delivery profile.Accordingly, in the embodiments described herein, catheter assembly 100is selectively switchable between a separated configuration, which maybe used for delivery of catheter assembly 100 to a pumping site, and anoperational configuration (i.e., for operation of catheter assembly 100at the pumping site). As the separated configuration is used fordelivery of catheter assembly 100, the separated configuration may alsobe referred to as a delivery configuration. In the separatedconfiguration, impeller body 308 is axially spaced from an expandablecannula 304 along a longitudinal axis 190 of catheter assembly 100. InFIG. 2, catheter assembly 100 is shown in the separated configuration.On the other hand, in the operational configuration, impeller body 308is located at the same axial position as expandable cannula 304.Specifically, impeller body 308 is positioned within expandable cannula304. The separated and operational configurations are described indetail herein.

Catheter assembly 100 is capable of being compressed or otherwisereduced to a substantially smaller cross-sectional profile in theseparated configuration, relative to the operational configuration. Forexample, distal end 108 of catheter assembly 100 may have across-sectional profile of approximately 11 French (approximately 3.5mm) in the separated configuration and a cross-sectional profile ofapproximately up to about 21 French (approximately 7 mm) in anoperational configuration. The larger profile in the operationalconfiguration facilitates greater blood flow rates driven by impellersystem 180. Although the above examples have been given, those of skillin the art will appreciate that other sizes for the separated andoperational configurations are within the scope of the presentdisclosure.

Catheter assembly 100 is configured to position distal end 108 in aheart chamber after being inserted initially into a peripheral vessel.For example, catheter assembly 100 may have a suitable length to reachthe left ventricle and sufficient maneuverability and torquability totraverse the intervening vasculature. In this embodiment, catheterassembly 100 includes a multilumen catheter body 120 that is arranged tofacilitate delivery and operation of impeller system 180 and expandablecannula 304. Further details concerning various embodiments of thecatheter body 120 are described in more detail in U.S. Pat. No.8,597,170, filed Jan. 34, 2012, which is incorporated by referenceherein in its entirety.

A drive system drives (i.e., rotates) one or more components of impellersystem 180, such as impeller body 308. The drive system includes motor14 coupled to a drive controller (not shown). The drive controller maybe integrated into control module 22 (shown in FIG. 1). Although motor14 may be configured to be disposed outside of the patient, in someembodiments, motor 14 may be sufficiently small such that motor isinsertable into the patient during use, including into the vasculature.

A torque coupling system transfers torque from motor 14 to impellersystem 180. An example torque coupling system is discussed further inU.S. Pat. No. 8,597,170, but in general may include a mechanical ormagnetic interface disposed between motor 14 and a drive assemblydisposed at proximal end 104 of catheter assembly 100. The driveassembly is coupled with a proximal end of an elongate drive shaft (notshown in FIG. 2) that extends through catheter body 120. A distalportion of the drive shaft is coupled to impeller system 180.

In at least some embodiments, motor 14 does not engage impeller system180 unless impeller body 308 is properly positioned within expandablecannula 304. Accordingly, impeller body 308 cannot be driven by motor 14when catheter assembly 100 is in the separated configuration.

FIG. 2 further shows an infusion inflow assembly 150 that can form apart of infusion system 26 (see FIG. 1). Infusion inflow assembly 150 isprovided adjacent proximal end 104 in one embodiment. Infusion system 26is configured to convey one or more fluids through catheter assembly 100during operation of impeller system 180. In one embodiment, an infusant,e.g., a medication or a lubricating fluid, such as saline or otherbeneficial medium, is conveyed distally along the pump, e.g., withincatheter body 120, toward the operating components adjacent to distalend 108. The infusant can include lubrication fluids such as glucose orother biocompatible lubricants. Infusion inflow assembly 150 includes aninfusion body 154 having a luer or other suitable connector 158 disposedat a proximal end thereof and in fluid communication with one or morelumens within catheter assembly 100. A lumen extending through infusionbody 154 is adapted to be fluidly coupled with a fluid source connectedto connector 158, to deliver the fluid into catheter assembly 100. Insome embodiments, catheter assembly 100 further includes an outer sheath(omitted in FIG. 2 for clarity) capable of selectively covering at leastone of impeller system 180 and expandable cannula 304.

As shown in FIG. 2, distal end 108 of catheter assembly 100 includes anatraumatic tip 312 disposed distal of impeller body 308. Atraumatic tip312 generally has an arcuate configuration such that atraumatic tip 312does not injure tissue when contacting tissue (e.g., the inner wall orendocardial surface of the ventricle). In some embodiments, atraumatictip 312 may include a 180° bend (not shown in the Figures), such thatatraumatic tip 312 forms a J-shaped tip. In yet another embodiment, thedistal-most end of atraumatic tip 312 may include one or more coils,forming a pigtail-shaped tip.

FIG. 3 is a schematic view of catheter assembly 100, showing variouscomponents of catheter assembly 100. Further, FIG. 3 shows catheterassembly 100 in the operational configuration. That is, FIG. 3 showsimpeller body 308 located at the same axial position (relative tolongitudinal axis 190) as expandable cannula 304 and positioned withinexpandable cannula 304.

Impeller body 308 is coupled to an impeller shaft 306, also referred toas a torque cable. Further, impeller shaft 306 is coupled to a motorshaft 307 driven by motor 14 (shown in FIG. 2). Accordingly, when motor14 rotates motor shaft 307, impeller shaft 306 and impeller body 308also rotate.

A guidewire lumen 309 extends through motor shaft 307, impeller shaft306, and impeller body 308. That is, motor shaft 307, impeller shaft306, and impeller body 308 define a passageway that receives guidewirelumen 309. Further, guidewire lumen 309 defines a passageway sized toreceive a guidewire (e.g., during delivery of catheter assembly 100)therethrough.

As shown in FIG. 3, guidewire lumen 309 extends distally beyond impellerbody 308. Further, guidewire lumen 309 is coupled to a distal bearing310 located distal of impeller body 308. Guidewire lumen 309 continuesto extend distally beyond distal bearing 310, and terminates in orcouples to atraumatic tip 312 (not shown in FIG. 3). In someembodiments, catheter assembly 100 does not include distal bearing 310.

In this embodiment, there is a radial clearance between guidewire lumen309 and motor shaft 307, impeller shaft 306, and impeller body 308. Thisclearance allows motor shaft 307, impeller shaft 306, and impeller body308 to all rotate about guidewire lumen 309 during operation of impellersystem 180. That is, guidewire lumen 309 (as well as distal bearing 310and atraumatic tip 312) are substantially stationary during rotation ofimpeller body 308.

Expandable cannula 304 is also stationary during rotation of impellerbody 308. Further, as shown in FIG. 3, expandable cannula 304 is coupledto a cannula shaft 316, which is also stationary during rotation ofimpeller body 308. Cannula shaft 316 is substantially hollow, andimpeller shaft 306 and guidewire lumen 309 extend through cannula shaft316.

FIGS. 4A and 4B illustrate a separated configuration 400 and anoperational configuration 402 of one embodiment of a catheter assembly401. FIGS. 5A and 5B illustrate a separated configuration 500 and anoperational configuration 502 of another embodiment of a catheterassembly 501. Unless otherwise indicated, components of the catheterassemblies 401 and 501 are substantially similar to those of catheterassembly 100.

In separated configurations 400 and 500, expandable cannula 304 andimpeller body 308 are axially spaced from one another along longitudinalaxis 190. This allows expandable cannula 304 and impeller body 308 to becompressed or collapsed (e.g., using a sheath or other delivery device)separate from one another, which results in an overall smallercross-sectional delivery profile of expandable cannula 304 and impellerbody 308.

In contrast, in operational configurations 402 and 502, expandablecannula 304 and impeller body 308 are located at the same axial positionalong longitudinal axis 190, such that impeller body 308 is positionedwithin expandable cannula 304. Expandable cannula 304 defines an inletzone 324, an outlet zone 326, and an impeller blade zone 328 betweeninlet zone 324 and outlet zone 326. In at least some embodiments, inletzone 324 is has a larger cross-sectional area than outlet zone 326 ofexpandable cannula 304. In operational configurations 402 and 502,impeller body 308 is positioned within impeller blade zone 328 ofexpandable cannula 304. Further, as described above, impeller system 180includes impeller shaft 306, impeller body 308 coupled to impeller shaft306, distal bearing 310, and atraumatic tip 312.

In some embodiments, a distal end of expandable cannula 304 flaresradially outward relative to longitudinal axis 190. As shown in FIGS. 4Band 5B, in operational configurations 402 and 502, distal bearing 310engages the flared distal end of expandable cannula 304, securingimpeller system 180 relative to expandable cannula 304. This is alsoshown in FIG. 3.

In catheter assembly 401, distal bearing 310 is a partial basket, orhalf-basket bearing. In contrast, in catheter assembly 501, distalbearing 310 is a full basket bearing. Partial basket bearings may bebeneficial in reducing overall delivery length of a catheter assembly.On the other hand, full basket bearings, while more complex, may providea stronger and more uniform radial force to interface with expandablecannula 304, and may have improved integration with atraumatic tip 312.

In the exemplary embodiment, an outer sheath 314 is configured toselectively cover expandable cannula 304 and impeller system 180. InFIGS. 4A, 4B, 5A, and 5B, for clarity, outer sheath 314 is shown in anunsheathed position (i.e., not covering expandable cannula 304 andimpeller system 180). However, during delivery, outer sheath 314generally covers expandable cannula 304 and impeller system 180, atleast partially collapsing expandable cannula 304 and impeller system180 into a delivery profile, and further reducing the cross-sectionalprofile of expandable cannula 304 and impeller system 180.

To transition between the separated configuration and the operationalconfiguration, catheter assemblies 401 and 501 include an actuator 318.For example, actuator 318 may be implemented as first and secondcomponents that are slidable relative to one another, the firstcomponent coupled to impeller system 180 and the second componentcoupled to expandable cannula 304. One such embodiment is describedbelow in association with FIGS. 6A and 6B.

Further, in some embodiments, an input device 322 on actuator 318 allowsa user to selectively transition catheter assemblies 401 and 501 betweenthe separated configuration and the operational configuration. Inputdevice 322 may be a knob or a button. For example, a knob coupled to afirst component (which is in turn coupled to impeller system 180) mayassist a user in sliding the first component relative to a secondcomponent coupled to expandable cannula 304. One such embodiment isdescribed below in association with FIGS. 7A and 7B. Alternatively,input device 322 may be any device that enables a user to transitioncatheter assemblies 401 and 501 between the separated configuration andthe operational configuration.

Further, in other embodiments, actuator 318 may include other suitablecomponents for selectively transitioning catheter assembly 401 and 501between the separated configuration and the operational configuration.For example, in some embodiments, actuator includes a spring (not shown)or other biasing mechanism that biases actuator towards one of theseparated configuration and the operational configuration. In such anembodiment, activating the input device 322 (e.g., pressing a button)allows the spring to expand, causing a transition from one configurationto the other. In other embodiments, an actuator motor (not shown) orother electromechanical device may be used to selectively transitioncatheter assembly 401 and 501 between the separated configuration andthe operational configuration. In such embodiments, operation of theactuator motor (e.g., in response to a user depressing a button) causesimpeller system 180 to translate relative to expandable cannula 304.

In addition, in some embodiments, actuator 318 includes one or morevisual indicators that enable a user to quickly and easily ascertainwhether the catheter assembly 401 or 501 is in the separatedconfiguration or the operational configuration. The visual indicatorsmay include, for example, one or more indicia on actuator 318 that areonly visible when catheter assembly 401 or 501 is in one of theseparated configuration or the operational configuration (and notvisible in the other configuration), a gauge or other readout indicatingthe current configuration, etc.

Further, in some embodiments, a locking mechanism (not shown) maintainscatheter assembly 401 or 501 in the operational configuration.Accordingly, during operation, catheter assembly 401 or 501 cannot beinadvertently or accidentally transitioned from the operationalconfiguration to the separated configuration. Instead, to transitionfrom the operational configuration to the separated configuration, theuser would have to first disengage the locking mechanism.

As described above, during delivery, catheter assembly 401 or 501 is inthe separated configuration (shown in FIGS. 4A and 5B). Once a targetsite is reached, a user engages input device 322 (e.g., by depressing abutton), causing actuator 318 to transition catheter assembly 401 or 501from the separated configuration the operational configuration.Specifically, in response to user engaging input device 322, impellerbody 308 translates proximally along longitudinal axis 190 relative toexpandable cannula 304, and into impeller blade zone 328 of expandablecannula 304.

To transition catheter assembly 401 or 501 back to the separatedconfiguration (e.g., to reposition or withdraw catheter assembly 401 or501), the user again engages input device 322. Specifically, in responseto user engaging input device 322, impeller body 308 translates distallyalong longitudinal axis 190 relative to expandable cannula 304, and outof impeller blade zone 328.

FIGS. 6A and 6B show on embodiment of actuator 318 in the separatedconfiguration and the operational configuration, respectively. As shownin FIGS. 6A and 6B, in this embodiment, actuator 318 includes animpeller anchor 602 and a cannula anchor 604. Further, in FIGS. 6A and6B, impeller shaft 306 is shown coupled to a follower magnet 610 ofmotor 14 that is operable to drive impeller shaft 306. Impeller anchor602 is slidable (i.e., along longitudinal axis 190) relative to cannulaanchor 604. Impeller anchor 602 is coupled to impeller shaft 306 suchthat translating impeller anchor 602 along longitudinal axis 190 causesimpeller shaft 306 (and thus, impeller body 308) to translate alonglongitudinal axis 190. Further, although impeller shaft 306 translateswith impeller anchor 602, impeller shaft 306 is also rotatably coupledto impeller anchor 602 (e.g., using rotary bearings (not shown)) suchthat impeller shaft 306 is rotatable relative to impeller anchor 602.Further, in this embodiment, cannula anchor 604 is fixedly coupled toexpandable cannula 304 and cannula shaft 316.

Accordingly, sliding impeller anchor 602 relative to cannula anchor 604causes impeller body 308 to translate relative to expandable cannula 304along longitudinal axis 190. As explained above, FIG. 6A shows actuator318 in the separated configuration and FIG. 6B shows actuator 318 in theoperational configuration. Accordingly, when transitioning from theseparated configuration to the operational configuration, impelleranchor 602 slides proximally relative to cannula anchor 604. This causesimpeller body 308 to slide proximally relative to expandable cannula304, and into impeller blade zone 328 of expandable cannula 304.

On the other hand, when transitioning from the operational configurationto the separated configuration, impeller anchor 602 slides distallyrelative to cannula anchor 604. This causes impeller body 308 to slidedistally relative to expandable cannula 304, and out of impeller bladezone 328 of expandable cannula 304. In the embodiment shown in FIGS. 6Aand 6B, a flared portion 620 of actuator 318 is part of impeller anchor602 and moves with impeller anchor 602. Impeller anchor 602 may be slidrelative to cannula anchor 604 using any input device 322.

For example, FIGS. 7A and 7B depict an embodiment of actuator 318 inwhich input device 322 is a slidable knob 700 that is fixedly coupled toimpeller anchor 602. Slidable knob 700 extends radially outward fromimpeller anchor 602 through a slot 702 defined in cannula anchor 604 andextending generally parallel to longitudinal axis 190. Further, slidableknob 700 is capable of translating along slot 702 (i.e., in a directiongenerally parallel to longitudinal axis 190). As slidable knob 700translates along slot 702, impeller anchor 602 slides relative tocannula anchor 604, transitioning actuator 318 between the separatedconfiguration and the operational configuration. In the embodiment shownin FIGS. 7A and 7B, flared portion 620 of actuator 318 is part ofcannula anchor 604 and moves with cannula anchor 604.

In some embodiments, slidable knob 700 may be biased (e.g., using aspring) toward one of the separated configuration and the operationalconfiguration. Further, in some embodiments, slot 702 may be partiallydefined by a seat or shoulder (e.g., a surface generally perpendicularto longitudinal axis 190) against which slidable knob 700 rests in theseparated configuration and/or the operational configuration.Alternatively, input device 322 may be any device that enablestransitioning between the separated configuration and the operationalconfiguration.

In some embodiments, at least one component of catheter assembly 100includes a memory shape material. For example, expandable cannula 304may include a memory shape alloy. Memory shape alloys (sometimesreferred to as shape memory alloys or materials) are compositions thatcan be deformed under stress but return to a specific shape once thatstress is released. A substrate that includes a memory shape alloy willreturn to its original shape multiple times with the application andrelease of deforming stress. Further, the change in shape of thesubstrate will also affect any coating on the surface of the substrate,and as such, any coating applied to the memory shape alloy should alsobe able to change shape without undergoing degradation.

Memory shape alloys display two distinct crystal forms: martensite andaustenite. The temperature and the internal stress of the systemdetermines the crystal form of a material. The martensite form typicallyexists at lower temperature while the austenite form exists at highertemperatures. At low temperatures, the martensite can be readilydeformed and shaped. When the temperature increases and the crystal formchanges from martensite to austenite, the austenite form “remembers” theshape it had before it was deformed and reverts back to that shape.Repeated use of the shape-memory effect may lead to a shift of thecharacteristic transformation temperatures (called functional fatigue)because it is closely related to the change in microstructural andfunctional properties of the material.

Examples of memory shape alloys suitable for use herein include, but arenot limited to, nickel-titanium (nitinol), copper-zinc,copper-zinc-aluminum, copper-aluminum-nickel, and gold-cadmium.

Because the surface of expandable cannula 304 is exposed to thevasculature of a patient, in some embodiments, expandable cannula 304 iscovered with a flexible material. In some aspects, the flexible materialis a biocompatible thermoplastic elastomer.

In some aspects, the biocompatible thermoplastic elastomer isindependently selected from the group consisting of a poly(urethane)block copolymer having both hard blocks and soft blocks, a poly(etheramide) block copolymer, poly(ether ester) block copolymer, apoly(olefin) vulcanized to comprise polar functional groups, apoly(styrene) vulcanized to comprise polar functional groups andcombinations thereof. In some embodiments, the biocompatiblethermoplastic elastomer comprises a poly(olefin) vulcanized to comprisepolar functional groups and/or a poly(styrene) vulcanized to comprisepolar functional groups where the functional groups are selected fromthe group consisting of maleic anhydride, acrylate, epoxy, amine, andcombinations thereof.

In some aspects, the polymer is a poly(urethane) block copolymercomprising at least one additional polymer block where, in addition tothe poly(urethane) block, the at least one additional block is selectedfrom the group consisting of poly(ether), poly(carbonate), poly(silane),poly(siloxane), poly(styrene), poly(vinylalcohol), poly(meth)acrylate,poly(acrylate), poly(urea), poly(urethane), poly(ethylene),poly(tetrafluoroethylene), poly(phenol), poly(ester), poly(amide),poly(peptide), and combinations thereof. If a second poly(urethane) isused, then the specific monomers used to prepare each poly(urethane)will be different, or the properties of each block will be differentfrom one another. Specific examples include, but are not limited to,Thoralon®, Carbosil®, Pursil®, Pellethane®, Elast-Elon®, Pellethane®,Tecoflex®, Tecothane®, Bionate®, Elast-Eon®, Pebax®, Vestamid®, Hytrel®,Arnitel®, Santoprene®, Selas®, Zelas®, Tresprene®, Kraton® andcombinations thereof. Desirably, the biocompatible thermoplasticelastomer is Thoralon®.

In yet another aspect, the biocompatible thermoplastic elastomer is apoly(urethane) block copolymer. When the polymer has two or more blocks,each block may be the same or different than any other block. Forexample, two different poly(urethanes) may be combined in a blockcopolymer. In another example, a poly(urethane-urea) block polymer isused. In yet another example, a poly(ether-siloxane-urethane) blockpolymer is used.

Also disclosed herein is method 800 for delivering or inserting catheterassembly having an expandable catheter and an impeller body to a targetsite. With reference to FIG. 8, method 800 includes placing 802 thecatheter assembly in a separated configuration. In the separatedconfiguration, an impeller body is axially spaced from the expandablecatheter along a longitudinal axis of the catheter assembly. Method 800further includes maneuvering 804 the catheter assembly to the targetsite while the catheter assembly is in the separated configuration.Method 800 further includes transitioning 806 the catheter assembly fromthe separated configuration to an operational configuration at thetarget site. In the operational configuration, the impeller body is atthe same axial position as the expandable cannula, and the impeller bodyis positioned inside of the expandable cannula. In some embodiments,transitioning 806 the catheter assembly includes moving a slidable knobon an actuator.

Although the embodiments and examples disclosed herein have beendescribed with reference to particular embodiments, it is to beunderstood that these embodiments and examples are merely illustrativeof the principles and applications of the present disclosure. It istherefore to be understood that numerous modifications can be made tothe illustrative embodiments and examples and that other arrangementscan be devised without departing from the spirit and scope of thepresent disclosure as defined by the claims. Thus, it is intended thatthe present application cover the modifications and variations of theseembodiments and their equivalents.

This written description uses examples to disclose the disclosure,including the best mode, and also to enable any person skilled in theart to practice the disclosure, including making and using any devicesor systems and performing any incorporated methods. The patentable scopeof the disclosure is defined by the claims, and may include otherexamples that occur to those skilled in the art. Such other examples areintended to be within the scope of the claims if they have structuralelements that do not differ from the literal language of the claims, orif they include equivalent structural elements with insubstantialdifferences from the literal languages of the claims.

What is claimed is:
 1. A catheter pump, comprising: an expandablecannula defining a blood flow channel and comprising an impeller bladezone, a single inlet zone including a flared portion that widensradially between a proximal end and a distal end to receive and securelyengage a bearing assembly, and an outlet zone; and an impeller systemcomprising an impeller body rotatably coupled to the bearing assembly,the impeller system movable relative to the expandable cannula along alongitudinal axis of the catheter pump, wherein the catheter pump isselectively transitionable between a separated configuration in whichthe impeller body and the bearing assembly are axially spaced from theexpandable cannula along the longitudinal axis, and an operationalconfiguration in which the impeller body is positioned within theimpeller blade zone of the expandable cannula and the bearing assemblyis engaged with the flared portion, thereby securing the impeller systemrelative to the expandable cannula, and wherein when the catheter pumpis in the separated configuration, the inlet zone includes the flaredportion, such that the flared portion is not held open by the bearingassembly and such that the flared portion is sizeable and shapeableaccording to a size and a shape of the impeller body and the bearingassembly before the impeller body and the bearing assembly are received.2. The catheter pump of claim 1, wherein the impeller system furthercomprises a guidewire lumen extending through the impeller body.
 3. Thecatheter pump of claim 2, wherein the impeller system further comprisesan atraumatic tip coupled to the guidewire lumen.
 4. The catheter pumpof claim 1, wherein the expandable cannula comprises a tubular stentframe formed from a shape memory material selected from the groupconsisting of nickel-titanium, copper-zinc, copper-zinc-aluminum,copper-aluminum-nickel, gold-cadmium and combinations thereof.
 5. Thecatheter pump of claim 1, wherein the expandable cannula is coated witha flexible material.
 6. The catheter pump of claim 1, wherein the inletzone of the expandable cannula has a larger cross-sectional area thanthe impeller blade zone of the expandable cannula.
 7. The catheter pumpof claim 6, wherein the bearing assembly is a partial basket bearing orfull basket bearing.
 8. The catheter pump of claim 7, wherein theimpeller system is configured such that the bearing assembly remainssubstantially stationary with respect to the expandable cannula duringrotation of the impeller body.
 9. The catheter pump of claim 1, furthercomprising: an actuator configured to transition the catheter pumpbetween the separated configuration and the operational configuration,the actuator including at least one indicium configured to visuallyindicate, outside a blood lumen of a patient when the impeller system isdisposed within the blood lumen of the patient, at least one of i) thatthe catheter pump is in the separated configuration, or ii) that thecatheter pump is in the operational configuration.
 10. The catheter pumpof claim 9, wherein the actuator comprises: an impeller anchor rotatablycoupled to the impeller system near a proximal end thereof, whereby atleast an impeller shaft of the impeller system is rotatable relative tothe impeller anchor, and a cannula anchor coupled to the expandablecannula near a proximal end thereof, the impeller anchor slidablerelative to the cannula anchor, whereby the impeller anchor isconfigured to translate axially relative to the cannula anchor to causethe catheter pump to transition between the separated configuration andthe operational configuration.
 11. The catheter pump of claim 10,wherein the impeller anchor is slidable relative to the cannula anchorby operation of a manually operable slidable knob fixedly coupled to theimpeller anchor near a proximal end of the impeller system and extendingradially outward from the impeller anchor through an opening defined bythe cannula anchor.
 12. A method of delivering a catheter pump having anexpandable cannula and an impeller system to a target site, the methodcomprising: placing the catheter pump in a separated configuration, inwhich an impeller body of the impeller system is axially spaced from theexpandable cannula along a longitudinal axis of the catheter pump;maneuvering the expandable cannula and impeller system to the targetsite while the catheter pump is in the separated configuration; andtransitioning the catheter pump from the separated configuration to anoperational configuration at the target site, wherein, in theoperational configuration, the impeller body is located at the sameaxial position as the expandable cannula, wherein in the operationalconfiguration, a bearing assembly, rotatably coupled to the impellerbody, is at least partially received within a flared portion of a singleinlet zone of the expandable cannula, such that the bearing assembly isheld stationary via engagement with the flared portion, and wherein,when the catheter pump is in the separated configuration, the inlet zoneincludes the flared portion, such that the flared portion is not heldopen by the bearing assembly and such that the flared portion issizeable and shapeable according to a size and a shape of the impellerbody and the bearing assembly before the impeller body and the bearingassembly are received.
 13. The method of claim 12, further comprising:inserting the expandable cannula and impeller body into a deliverysheath prior to maneuvering the expandable cannula and impeller systemto the target site; and removing the delivery sheath from the impellerbody and the expandable cannula at the target site.
 14. The method ofclaim 12, wherein transitioning the catheter pump from the separatedconfiguration to an operational configuration comprises operating anactuator coupled to the impeller system.
 15. The method of claim 14,wherein the actuator comprises: an impeller anchor rotatably coupled tothe impeller system, whereby at least an impeller shaft of the impellersystem is rotatable relative to the impeller anchor and a cannula anchorcoupled to the expandable cannula, and wherein operating the actuatorcomprises sliding the impeller anchor relative to the cannula anchor totranslate the impeller anchor axially relative to the cannula anchor andtransition the catheter pump between the separated configuration and theoperational configuration.
 16. The method of claim 15, wherein operatingan actuator comprises manipulating a knob coupled to the actuator,wherein the knob is fixedly coupled to the impeller anchor and extendsradially outward from the impeller anchor through an opening defined bythe cannula anchor.
 17. The method of claim 12, wherein transitioningthe catheter pump from the separated configuration to the operationalconfiguration comprises engaging a distal end of the expandable cannulawith the bearing assembly of the impeller system.
 18. The method ofclaim 12, further comprising operating the catheter pump by rotating theimpeller body while the bearing assembly remains substantiallystationary.
 19. The method of claim 12, wherein the impeller body ispositioned inside the expandable cannula in the operationalconfiguration.
 20. A catheter pump, comprising: an expandable cannuladefining a blood flow channel and comprising an impeller blade zone, asingle inlet zone including a flared portion that widens between aproximal end and a distal end to securely engage a portion of animpeller system; and the impeller system comprising an impeller body,the impeller system movable relative to the expandable cannula along alongitudinal axis of the catheter pump, wherein the catheter pump isselectively transitionable between a separated configuration in whichthe impeller body is axially spaced from the expandable cannula alongthe longitudinal axis, and an operational configuration in which theimpeller body is positioned within the impeller blade zone of theexpandable cannula and the portion of the impeller system is securelyengaged with the flared portion of the expandable cannula, therebysecuring the impeller system relative to the expandable cannula, andwherein when the catheter pump is in the separated configuration, theinlet zone includes the flared portion, such that the flared portion isnot held open by a bearing assembly and such that the flared portion issizeable and shapeable according to a size and a shape of the impellerbody and the bearing assembly before the impeller body and the bearingassembly are received.